Abstract
| Original language | English |
|---|---|
| Pages (from-to) | 2375-2381 |
| Number of pages | 7 |
| Journal | Leukemia and Lymphoma |
| Volume | 57 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - 2016 |
Keywords
- Chemotherapeutic approaches
- clinical results
- lymphoma and Hodgkin lymphoma
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B-IGEV (bortezomib plus IGEV) versus IGEV before high-dose chemotherapy followed by autologous stem cell transplantation in relapsed or refractory Hodgkin lymphoma: a randomized, phase II trial of the Fondazione Italiana Linfomi (FIL). / Balzarotti, M.; Brusamolino, Ercole; Angelucci, E. et al.
In: Leukemia and Lymphoma, Vol. 57, No. 10, 2016, p. 2375-2381.Research output: Contribution to journal › Article › peer-review
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TY - JOUR
T1 - B-IGEV (bortezomib plus IGEV) versus IGEV before high-dose chemotherapy followed by autologous stem cell transplantation in relapsed or refractory Hodgkin lymphoma: a randomized, phase II trial of the Fondazione Italiana Linfomi (FIL)
AU - Balzarotti, M.
AU - Brusamolino, Ercole
AU - Angelucci, E.
AU - Carella, A.M.
AU - Vitolo, U.
AU - Russo, E.
AU - Congiu, A.
AU - Gotti, M.
AU - Massidda, Stefania
AU - Botto, B.
AU - Annechini, Giorgia
AU - Spina, M.
AU - Re, A.
AU - Zilioli, Vittorio Ruggero
AU - Merli, F.
AU - Salvi, F.
AU - Stelitano, Caterina
AU - Bonfichi, M.
AU - Rodari, M.
AU - Murru, Roberta
AU - Magagnoli, Massimo
AU - Anastasia, A.
AU - Mazza, R.
AU - Giordano, L.
AU - Santoro, A.
N1 - Export Date: 16 March 2017 CODEN: LELYE Correspondence Address: Santoro, A.; Humanitas Cancer CenterItaly; email: armando.santoro@cancercenter.humanitas.it References: Linch, D.C., Winfield, D., Goldstone, A.H., Dose intensification with autologous bone-marrow transplantation in relapsed and resistant Hodgkin's disease: results of a BNLI randomised trial (1993) Lancet, 341, pp. 1051-1054; Schmitz, N., Pfistner, B., Sextro, M., Aggressive conventional chemotherapy compared with high-dose chemotherapy with autologous haemopoietic stem-cell transplantation for relapsed chemosensitive Hodgkin's disease: a randomised trial (2002) Lancet, 359, pp. 2065-2071; Rancea, M., von Tresckow, B., Monsef, I., High-dose chemotherapy followed by autologous stem cell transplantation for patients with relapsed or refractory Hodgkin lymphoma: a systematic review with meta-analysis (2014) Crit Rev Oncol Hematol, 92, pp. 1-10; Spaepen, K., Stroobants, S., Dupont, P., Prognostic value of pretransplantation positron emission tomography using fluorite 18-fluorodexygluocse in patients with aggressive lymphoma treated with high-dose chemotherapy and stem–cell transplantation (2003) Blood, 102, pp. 53-59; Filmont, J.E., Czernin, J., Yap, C., Value of F-18 fluorodexyglucose positron emission tomography for predicting the clinical outcome of patients with aggressive lymphoma prior and after autologous stem-cell transplantation (2006) Chest, 124, pp. 608-613; Moskowitz, C.H., Matasar, M.J., Zelenetz, A.D., Normalization of pre-ASCT, FDG-PET imaging with second-line, non-cross-resistant, chemotherapy programs improves event-free survival in patients with Hodgkin lymphoma (2012) Blood, 119, pp. 1665-1670; Mazza, R., Luminari, S., Magagnoli, M., Pretransplatation PET as major prognostic discriminant in IGEV (ifosfamide, gemcitabine, vinorelbine and prednisone) treated patients with relapsed/refractory Hodgkin’s lymphoma (HL) (2009) Blood, 114, p. 3707; Velasquez, W.S., Cabanillas, F., Salvador, P., Effective salvage therapy for lymphoma with cisplatin in combination with high-dose Ara-C and dexamethasone (DHAP) (1988) Blood, 71, pp. 117-122; Velasquez, W.S., McLaughlin, P., Tucker, S., ESHAP – an effective chemotherapy regimen in refractory and relapsing lymphoma: a 4-year follow-up study (1994) J Clin Oncol, 12, pp. 1169-1176; Martin, A., Fernandez-Jimenez, M.C., Caballero, M.D., Long-term follow-up in patients treated with Mini-BEAM as salvage therapy for relapsed or refractory Hodgkin's disease (2001) Br J Haematol, 113, pp. 161-171; Moskowitz, C.H., Nimer, S.D., Zelenetz, A.D., A 2-step comprehensive high-dose chemoradiotherapy second-line program for relapsed and refractory Hodgkin disease: analysis by intent to treat and development of a prognostic model (2001) Blood, 97, pp. 616-623; Moskowitz, C.H., Kewalramani, T., Nimer, S.D., Effectiveness of high dose chemoradiotherapy and autologous stem cell transplantation for patients with biopsy-proven primary refractory Hodgkin's disease (2004) Br J Haematol, 124, pp. 645-652; Santoro, A., Magagnoli, M., Spina, M., Ifosfamide, gemcitabine, and vinorelbine: a new induction regimen for refractory and relapsed Hodgkin's lymphoma (2007) Haematologica, 92, pp. 35-41; O'Connor, O.A., Moskowitz, C., Portlock, C., Patients with chemotherapy-refractory mantle cell lymphoma experience high response rates and identical progression-free survivals compared with patients with relapsed disease following treatment with single agent bortezomib: results of a multicentre Phase 2 clinical trial (2009) Br J Haematol, 145, pp. 34-39; O'Connor, O.A., Wright, J., Moskowitz, C., Phase II clinical experience with the novel proteasome inhibitor bortezomib in patients with indolent non-Hodgkin's lymphoma and mantle cell lymphoma (2005) J Clin Oncol, 23, pp. 676-684; Pajonk, F., Pajonk, P., MvBride, W.H., Apoptosis and radiosensitization of Hodgkin cells by proteasome inhibition (2000) Int J Radiat Oncol Biol Phys, 47, pp. 1025-1032; Fahy, B.N., Schlieman, M.G., Virudachalam, S., Schedule-dependent molecular effects of the proteasome inhibitor bortezomib and gemcitabine in pancreatic cancer (2003) J Surg Res, 113, pp. 88-95; Kamat, A.M., Karashima, T., Davis, D.W., Proteasome inhibitor bortezomib synergizes with gemcitabine to block the growth of human 253JB-V bladder tumors in vivo (2004) Mol Cancer Ther, 3, pp. 279-290; Rakumar, V.S., multiple myeloma: update on diagnosis, risk stratification, and management (2014) Am J Hematol, 89, pp. 999-1009; Bommakanti, S.V., Dudek, A., Phase 1 trial of gemcitabine with bortezomib in elderly patients with advanced solid tumors (2001) Am J Clin Oncol, 34, pp. 597-602; Cheson, B.D., Pfistner, B., Juweid, M.E., Revised response criteria for malignant lymphoma (2007) J Clin Oncol, 25, pp. 579-586; Younes, A., Pro, B., Fayad, L., Experience with bortezomib for the treatment of patients with relapsed classical Hodgkin lymphoma (2006) Blood, 107, pp. 1731-1732; Blum, K.A., Johnson, J.L., Niedzwiecki, D., Single agent bortezomib in the treatment of relapsed and refractory Hodgkin lymphoma: cancer and leukemia Group B protocol 50206 (2007) Leuk Lymphoma, 48, pp. 1313-1319; Mendler, J.H., Kelly, J., Voci, S., Bortezomib and gemcitabine in relapsed or refractory Hodgkin's lymphoma (2008) Ann Oncol, 19, pp. 1759-1764; Trelle, S., Sezer, O., Naumann, R., Bortezomib in combination with dexamethasone for patients with relapsed Hodgkin's lymphoma: results of a prematurely closed phase II study (NCT00148018) (2007) Haematologica, 92, pp. 68-69; Fanale, M., Fayad, L., Pro, B., Phase I study of bortezomib plus ICE (BICE) for the treatment of relapsed/refractory Hodgkin lymphoma (2011) Br J Haematol, 154, pp. 284-286; Karuturi, M., Younes, A., Fayad, L., ICE (Ifosfamide, Carboplatin, Etoposide) with or without bortezomib in patients with relapsed/refractory Hodgkin lymphoma: results of a randomized phase II trial (2015) Leuk Lymph, 25, pp. 1-8; Anastasia, A., Carlo-Stella, C., Corradini, P., Bendamustine for Hodgkin lymphoma patients failing autologous or autologous and allogeneic stem cell transplantation: a retrospective study of the Fondazione Italiana Linfomi (2014) Br J Haematol, 166, pp. 140-142; Younes, A., Gopal, A.K., Smith, S.E., Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma (2012) J Clin Oncol, 30, pp. 2183-2189; Ansell, S.M., Lesokhin, A.M., Borrello, I., PD-1 blockade with nivolumab in relapsed or refractory Hodgkin's lymphoma (2015) N Engl J Med, 372, pp. 311-319
PY - 2016
Y1 - 2016
N2 - This randomized, multicenter study evaluates the addition of bortezomib (13 mg/m2) to IGEV (B-IGEV) in patients with relapsed/refractory Hodgkin Lymphoma (HL). Patients received either four courses of IGEV alone (n = 40) or B-IGEV (n = 40). The primary endpoint was the complete response (CR) proportion, evaluated by FDG-PET, after induction chemotherapy. CR proportion was 39% with B-IGEV and 53% with IGEV. PFS and OS were similar between the two groups (two-year PFS: 58% vs 56%; two-year OS: 93% vs 81%). The PET-negative status after treatment was the only variable favorably influencing both PFS (two-year PFS: 77% vs 40%; p = 0.002) and OS (two-year OS: 100% vs 76%; p < 0.001). Toxicity was overall similar with the two regimens. The addition of bortezomib to IGEV does not improve response in relapsed/refractory HL patients. However, its favorable therapeutic and safety profile, and the prognostic role of pre-transplant PET negativity in patients receiving IGEV-based regimens are confirmed. © 2016 Informa UK Limited, trading as Taylor & Francis Group.
AB - This randomized, multicenter study evaluates the addition of bortezomib (13 mg/m2) to IGEV (B-IGEV) in patients with relapsed/refractory Hodgkin Lymphoma (HL). Patients received either four courses of IGEV alone (n = 40) or B-IGEV (n = 40). The primary endpoint was the complete response (CR) proportion, evaluated by FDG-PET, after induction chemotherapy. CR proportion was 39% with B-IGEV and 53% with IGEV. PFS and OS were similar between the two groups (two-year PFS: 58% vs 56%; two-year OS: 93% vs 81%). The PET-negative status after treatment was the only variable favorably influencing both PFS (two-year PFS: 77% vs 40%; p = 0.002) and OS (two-year OS: 100% vs 76%; p < 0.001). Toxicity was overall similar with the two regimens. The addition of bortezomib to IGEV does not improve response in relapsed/refractory HL patients. However, its favorable therapeutic and safety profile, and the prognostic role of pre-transplant PET negativity in patients receiving IGEV-based regimens are confirmed. © 2016 Informa UK Limited, trading as Taylor & Francis Group.
KW - Chemotherapeutic approaches
KW - clinical results
KW - lymphoma and Hodgkin lymphoma
U2 - 10.3109/10428194.2016.1140161
DO - 10.3109/10428194.2016.1140161
M3 - Article
VL - 57
SP - 2375
EP - 2381
JO - Leukemia and Lymphoma
JF - Leukemia and Lymphoma
SN - 1042-8194
IS - 10
ER -